X-Spectra Flavoured Tablets for Large Dogs
Country: France
Language: English
Source: HMA (Heads of Medicines Agencies)
Summary of Product characteristics
(SPC)
23-04-2013
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Active ingredient:
febantel 525 mg, praziquantel 175 mg, pyrantel 175 mg
Available from:
CEVA Animal Health
ATC code:
QP52AA51
Pharmaceutical form:
Tablet
Therapeutic group:
praziquantel, combinations
Therapeutic area:
Dogs
Authorization date:
2011-11-23
Summary of Product characteristics
AN: 00824/2012
Revised: February 2013
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
X-SPECTRA Flavoured tablets for medium and small dogs [UK]
CESTEM F tablets for dogs [FR]
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One tablet contains:
ACTIVE SUBSTANCES:
Febantel ................................................................................. 150 mg
Pyrantel (as embonate) .......................................................... 50 mg
Praziquantel ............................................................................. 50 mg
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
Yellow brown, oval tablet with a score line on both sides.
The tablets can be divided into equal halves.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment of mixed infections by cestodes and nematodes of the following
species:
Nematodes:
Ascarids:
_Toxocara canis_, _Toxascaris leonina _(adult and late immature
forms)_ _.
Hookworms: _Uncinaria stenocephala_, _Ancylostoma caninum _(adults).
Whipworms: _Trichuris vulpis _(adults).
Cestodes:
Tapeworms: _Echinococcus _species, _(E. Granulosus, E. Multilocularis), Taenia _
species (T. hydatigena, T. pisiformis, T. taeniformis), _Dipylidium caninum _(adult
and immature forms).
AN: 00824/2012
Revised: February 2013
Page 2 of 6
4.3
CONTRAINDICATIONS
Do not use in animals with a known sensitivity to the active ingredients or to any
of the excipients.
See section 4.7 below.
4.4 SPECIAL WARNINGS FOR EACH TARGET
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